LEVOTHYROXINE SODIUM

Product NDC: 33342-394
11-digit product format: 333420394
Labeler code: 33342
Product ID: 33342-394_3a77ca51-7d8a-4755-aabc-3801cc772a10
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LEVOTHYROXINE SODIUM
Dosage form: TABLET
Route: ORAL
Labeler: Macleods Pharmaceuticals Limited
Application: ANDA211417
Marketing category: ANDA
Marketing start: 2022-12-21
Substance: LEVOTHYROXINE SODIUM
Active strength: 50 ug/1
Pharmacologic classes: Thyroxine [CS], l-Thyroxine [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 12 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A211417-001	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21
A211417-002	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21
A211417-003	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21
A211417-004	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21
A211417-005	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21
A211417-006	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21
A211417-007	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21
A211417-008	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21
A211417-009	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21
A211417-010	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21
A211417-011	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21
A211417-012	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 48 matching rows.

Application-product, TE code table
Application-product	TE code
A211417-001	AB1
A211417-001	AB2
A211417-001	AB3
A211417-001	AB4
A211417-002	AB1
A211417-002	AB2
A211417-002	AB3
A211417-002	AB4
A211417-003	AB1
A211417-003	AB2
A211417-003	AB3
A211417-003	AB4
A211417-004	AB1
A211417-004	AB2
A211417-004	AB3
A211417-004	AB4
A211417-005	AB1
A211417-005	AB2
A211417-005	AB3
A211417-005	AB4
A211417-006	AB1
A211417-006	AB2
A211417-006	AB3
A211417-006	AB4
A211417-007	AB1
A211417-007	AB2
A211417-007	AB3
A211417-007	AB4
A211417-008	AB1
A211417-008	AB2
A211417-008	AB3
A211417-008	AB4
A211417-009	AB1
A211417-009	AB2
A211417-009	AB3
A211417-009	AB4
A211417-010	AB1
A211417-010	AB2
A211417-010	AB3
A211417-010	AB4
A211417-011	AB1
A211417-011	AB2
A211417-011	AB3
A211417-011	AB4
A211417-012	AB1
A211417-012	AB2
A211417-012	AB3
A211417-012	AB4

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 8 · 288 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211417-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-005	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-006	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-007	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-008	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-009	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-010	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-011	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-012	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211417-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211417-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211417-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211417-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211417-005	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211417-006	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211417-007	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211417-008	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211417-009	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211417-010	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211417-011	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211417-012	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211417-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211417-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211417-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211417-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211417-005	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211417-006	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211417-007	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211417-008	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211417-009	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211417-010	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211417-011	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211417-012	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211417-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211417-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211417-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211417-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 14 · 540 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211417-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-001	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-001	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-001	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-002	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-002	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-002	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-003	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-003	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-003	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-003	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-004	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-004	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-004	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-004	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-005	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-005	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-005	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-005	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-006	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-006	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-006	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-006	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-007	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-007	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-007	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-007	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-008	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-008	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-008	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-008	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-009	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-009	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-009	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-009	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-010	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-010	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-010	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-010	AB4	4	`011fe1cb6892…`

Additional Listing Data#

Finished product: Yes
Brand name base: LEVOTHYROXINE SODIUM
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEVOTHYROXINE SODIUM	50 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9J765S329G	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
892246	Internal RxNorm lookup
892251	Internal RxNorm lookup
892255	Internal RxNorm lookup
966220	Internal RxNorm lookup
966221	Internal RxNorm lookup
966222	Internal RxNorm lookup
966224	Internal RxNorm lookup
966225	Internal RxNorm lookup
966248	Internal RxNorm lookup
966249	Internal RxNorm lookup
966253	Internal RxNorm lookup
966270	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
b8c20f76-3ee6-4b29-b77f-ed4ad1baaed9	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
97c252d3-9bb8-4530-bb44-9824dc7cf556	Product name	6	20250729
6c43b71c-35e6-4db3-ba24-c6ef42ff7003	Product name	3	20240207
890fd4bf-1a80-42b7-be1b-2d0259d5f0c8	Product name	5	20240207
c8ad26bf-af73-460b-b74e-1eff16cc4f9f	Product name	5	20240207
01383843-4069-43cf-aa76-dc17a6f9f8c4	Product name	2	20230123
978cca7d-a938-4791-8322-da48d90a63ef	Product name	1	20230113
65f86ba3-8816-4e12-899b-18290c8de551	Product name	2	20210614
f16ab90f-08c2-40be-a543-66d9827cd1f3	Product name	1	20210601
6a33ec05-2ae2-45e5-ab82-2d94b3303923	Product name	1	20190709
93355a10-1c44-4c92-a11d-7d995e0200d9	Product name	1	20190219

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
33342-394-10	LEVOTHYROXINE SODIUM	90 in 1 BOTTLE	TABLET	90	3
33342-394-11	LEVOTHYROXINE SODIUM	100 in 1 BOTTLE	TABLET	100	3
33342-394-44	LEVOTHYROXINE SODIUM	1000 in 1 BOTTLE	TABLET	1000	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
33342-394	LEVOTHYROXINE SODIUM TABLET [MACLEODS PHARMACEUTICALS LIMITED]	3	Current NDC, Legacy NDC, 3 package rows	20240323_b8c20f76-3ee6-4b29-b77f-ed4ad1baaed9.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	Coupler LLC	5383a4d8-319a-5bf6-e063-6294a90a5497	2026-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211417 application number: ANDA211417
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	NuCare Pharmaceuticals,Inc.	510349d0-6397-7e2b-e063-6394a90a8a68	2026-05-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211417 application number: ANDA211417
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	NorthStar RxLLC	58f4dc90-3648-49dc-a7e1-baf918a773b5	2026-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211417 application number: ANDA211417
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	A-S Medication Solutions	853d9e86-2b5b-4967-8c22-70ad34f03418	2026-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211417 application number: ANDA211417
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	A-S Medication Solutions	b42fe9dd-8383-4839-9eab-393de388da71	2026-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211417 application number: ANDA211417
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	A-S Medication Solutions	394b1006-c160-4668-8684-82d1c4481202	2026-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211417 application number: ANDA211417
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	A-S Medication Solutions	8e11401b-f5c2-42ac-ba63-2e71b5626b7e	2026-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211417 application number: ANDA211417
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	A-S Medication Solutions	2b737395-0238-400b-95ff-890b95c98425	2026-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211417 application number: ANDA211417
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	A-S Medication Solutions	1ac29774-2b53-4a3f-97fa-16c2880a0868	2026-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211417 application number: ANDA211417
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	NuCare Pharmaceuticals, Inc.	3d737f79-7fc9-4221-e063-6394a90ac9aa	2026-01-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211417 application number: ANDA211417
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	A-S Medication Solutions	2adb05ef-b3fa-4ac2-b219-99442746392b	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211417 application number: ANDA211417
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	A-S Medication Solutions	d5b005e8-a88d-450b-bbc3-393d885260f5	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211417 application number: ANDA211417
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	A-S Medication Solutions	2aab0208-81ad-4607-8196-b4dc5ad5fdaa	2025-09-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211417 application number: ANDA211417
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	A-S Medication Solutions	194bc35b-ac82-4a40-bbd4-68eaff50b380	2025-09-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211417 application number: ANDA211417
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	A-S Medication Solutions	37a55040-a9a2-4ff4-8463-9e1c7823d6ff	2025-08-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211417 application number: ANDA211417
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	A-S Medication Solutions	2e242b93-bc4f-405a-a194-1981c721ad94	2025-08-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211417 application number: ANDA211417
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	REMEDYREPACK INC.	817656c7-3b6d-4f94-83e6-dec9e0d35c84	2025-08-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211417 application number: ANDA211417
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	REMEDYREPACK INC.	6f4bc4be-17a7-4273-a8d9-a1ff036dea0e	2025-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211417 application number: ANDA211417
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	REMEDYREPACK INC.	9ad82faf-3734-42a1-befe-f6197b27f534	2025-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211417 application number: ANDA211417
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals Inc.	609352a9-740f-4874-997b-60b58d0c2b8a	2025-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211417 application number: ANDA211417

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9J765S329G	LEVOTHYROXINE SODIUM	6106-07-6	LEVOTHYROXINE SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
892246	levothyroxine sodium 100 MCG Oral Tablet	PSN	b8c20f76-3ee6-4b29-b77f-ed4ad1baaed9	3
966248	levothyroxine sodium 112 MCG Oral Tablet	PSN	b8c20f76-3ee6-4b29-b77f-ed4ad1baaed9	3
966224	levothyroxine sodium 125 MCG Oral Tablet	PSN	b8c20f76-3ee6-4b29-b77f-ed4ad1baaed9	3
966270	levothyroxine sodium 137 MCG Oral Tablet	PSN	b8c20f76-3ee6-4b29-b77f-ed4ad1baaed9	3
966225	levothyroxine sodium 150 MCG Oral Tablet	PSN	b8c20f76-3ee6-4b29-b77f-ed4ad1baaed9	3
966249	levothyroxine sodium 175 MCG Oral Tablet	PSN	b8c20f76-3ee6-4b29-b77f-ed4ad1baaed9	3
892251	levothyroxine sodium 200 MCG Oral Tablet	PSN	b8c20f76-3ee6-4b29-b77f-ed4ad1baaed9	3
966220	levothyroxine sodium 25 MCG Oral Tablet	PSN	b8c20f76-3ee6-4b29-b77f-ed4ad1baaed9	3
892255	levothyroxine sodium 300 MCG Oral Tablet	PSN	b8c20f76-3ee6-4b29-b77f-ed4ad1baaed9	3
966221	levothyroxine sodium 50 MCG Oral Tablet	PSN	b8c20f76-3ee6-4b29-b77f-ed4ad1baaed9	3
966222	levothyroxine sodium 75 MCG Oral Tablet	PSN	b8c20f76-3ee6-4b29-b77f-ed4ad1baaed9	3
966253	levothyroxine sodium 88 MCG Oral Tablet	PSN	b8c20f76-3ee6-4b29-b77f-ed4ad1baaed9	3
966220	levothyroxine sodium 0.025 MG Oral Tablet	SCD	b8c20f76-3ee6-4b29-b77f-ed4ad1baaed9	3
966221	levothyroxine sodium 0.05 MG Oral Tablet	SCD	b8c20f76-3ee6-4b29-b77f-ed4ad1baaed9	3
966222	levothyroxine sodium 0.075 MG Oral Tablet	SCD	b8c20f76-3ee6-4b29-b77f-ed4ad1baaed9	3
966253	levothyroxine sodium 0.088 MG Oral Tablet	SCD	b8c20f76-3ee6-4b29-b77f-ed4ad1baaed9	3
892246	levothyroxine sodium 0.1 MG Oral Tablet	SCD	b8c20f76-3ee6-4b29-b77f-ed4ad1baaed9	3
966248	levothyroxine sodium 0.112 MG Oral Tablet	SCD	b8c20f76-3ee6-4b29-b77f-ed4ad1baaed9	3
966224	levothyroxine sodium 0.125 MG Oral Tablet	SCD	b8c20f76-3ee6-4b29-b77f-ed4ad1baaed9	3
966270	levothyroxine sodium 0.137 MG Oral Tablet	SCD	b8c20f76-3ee6-4b29-b77f-ed4ad1baaed9	3
966225	levothyroxine sodium 0.15 MG Oral Tablet	SCD	b8c20f76-3ee6-4b29-b77f-ed4ad1baaed9	3
966249	levothyroxine sodium 0.175 MG Oral Tablet	SCD	b8c20f76-3ee6-4b29-b77f-ed4ad1baaed9	3
892251	levothyroxine sodium 0.2 MG Oral Tablet	SCD	b8c20f76-3ee6-4b29-b77f-ed4ad1baaed9	3
892255	levothyroxine sodium 0.3 MG Oral Tablet	SCD	b8c20f76-3ee6-4b29-b77f-ed4ad1baaed9	3
892246	levothyroxine sodium 100 MCG Oral Tablet	SY	b8c20f76-3ee6-4b29-b77f-ed4ad1baaed9	3
966248	levothyroxine sodium 112 MCG Oral Tablet	SY	b8c20f76-3ee6-4b29-b77f-ed4ad1baaed9	3
966224	levothyroxine sodium 125 MCG Oral Tablet	SY	b8c20f76-3ee6-4b29-b77f-ed4ad1baaed9	3
966270	levothyroxine sodium 137 MCG Oral Tablet	SY	b8c20f76-3ee6-4b29-b77f-ed4ad1baaed9	3
966225	levothyroxine sodium 150 MCG Oral Tablet	SY	b8c20f76-3ee6-4b29-b77f-ed4ad1baaed9	3
966249	levothyroxine sodium 175 MCG Oral Tablet	SY	b8c20f76-3ee6-4b29-b77f-ed4ad1baaed9	3
892251	levothyroxine sodium 200 MCG Oral Tablet	SY	b8c20f76-3ee6-4b29-b77f-ed4ad1baaed9	3
966220	levothyroxine sodium 25 MCG Oral Tablet	SY	b8c20f76-3ee6-4b29-b77f-ed4ad1baaed9	3
892255	levothyroxine sodium 300 MCG Oral Tablet	SY	b8c20f76-3ee6-4b29-b77f-ed4ad1baaed9	3
966221	levothyroxine sodium 50 MCG Oral Tablet	SY	b8c20f76-3ee6-4b29-b77f-ed4ad1baaed9	3
966222	levothyroxine sodium 75 MCG Oral Tablet	SY	b8c20f76-3ee6-4b29-b77f-ed4ad1baaed9	3
966253	levothyroxine sodium 88 MCG Oral Tablet	SY	b8c20f76-3ee6-4b29-b77f-ed4ad1baaed9	3
966221	levothyroxine sodium 50 MCG Oral Tablet	PSN	609352a9-740f-4874-997b-60b58d0c2b8a	1
966221	levothyroxine sodium 0.05 MG Oral Tablet	SCD	609352a9-740f-4874-997b-60b58d0c2b8a	1
966221	levothyroxine sodium 50 MCG Oral Tablet	SY	609352a9-740f-4874-997b-60b58d0c2b8a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
33342-394-10	33342039410	90 TABLET in 1 BOTTLE (33342-394-10)	90 tablet	2022-12-21	0000-00-00	No	No	Current
33342-394-11	33342039411	100 TABLET in 1 BOTTLE (33342-394-11)	100 tablet	2022-12-21	0000-00-00	No	No	Current
33342-394-44	33342039444	1000 TABLET in 1 BOTTLE (33342-394-44)	1000 tablet	2023-01-24		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals Inc.	2025-08-01	HUMAN PRESCRIPTION DRUG LABEL	1
LEVOTHYROXINE SODIUM	Macleods Pharmaceuticals Limited	2024-03-04	Human Prescription Drug Label	3